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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K253771
Device Name Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13)
Applicant
Nanjing Devin Medical Technology Co., Ltd.
Bldg. 9, 3rd Floor, # 86, Shuanggao Rd., Economic Developmen
Nanjing,  CN 211300
Applicant Contact Qiuling Liu
Correspondent
APlus Healthcare Technology (Shanghai) Co., Ltd.
1201 Floor, Zhongzhi Bldg., #9299 Humin Rd., Xuhui District
Shanghai,  CN
Correspondent Contact Jack Fang
Regulation Number878.4400
Classification Product Code
NEY  
Date Received11/26/2025
Decision Date 03/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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